Associate Director, tLNP Formulation

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

We are seeking a leader responsible for the oversight of formulation development, sterile fill-finish process development, scale-up, tech transfer and manufacture of targeted lipid nanoparticles (tLNPs) for pre-clinical and clinical studies. The successful candidate should demonstrate his/her ability in establishing and leading a growing formulation team and will work seamlessly with external manufacturing organizations to complete GMP testing. In addition, the incumbent will be expected to establish systems in the department to enable manufacturing of the batches for non-clinical safety studies and clinical studies under GMP. The candidate will oversee work on a cross-functional product development team including liaising with Biologics CMC, Synthetic Molecule CMC, Clinical Operations, Regulatory Affairs including addressing requests for Health Authorities, and Quality Assurance in development and commercialization of drug products.

Responsibilities:

• Responsible for overseeing formulation development of targeted lipid nanoparticles (tLNPs) entering FIH, as well as formulation optimization and commercial formulation definition prior to pivotal clinical trials.
• Responsible for evaluation of novel product presentations for tLNPs, which may include a lyophile, spray dried powder, nonaqueous suspension, or other advanced presentations, and the process development thereof.
• Designs, oversees, and reviews clinical in-use studies to evaluate the stability and compatibility of tLNP drug products.
• Manages contract development and manufacturing organizations (CDMOs) involved in sterile fill finish operations of tLNPs.
• Reviews and approves documents related to formulation development and drug product production, including technical transfer, process development reports, qualifications, master and executed batch records, and campaign summary report.
• Works closely with others in CMC and quality assurance to lead investigations and data analysis to address deviations/non-conformance and implement change controls to ensure timely/prompt release of batches.
• Authors and reviews drug product sections for regulatory submissions.
• Contributes to the development and monitoring of departmental goals and budgets.

Qualifications

• PhD. in Chemistry, Molecular Biology, Chemical or Bioengineering and 8+ years of related experience, or MS/BS with 14/16+ years of related experience
• Extensive experience working with protein therapeutics, antibodies, conjugation chemistries, and genetic medicines including LNPs
• Experience with process development, analytical characterization, process scale-up, and/ or regulatory descriptions of drug product manufacturing processes/registration
• Experience with project management with external partners
• Experience with GxP/ GMP production
• Familiarity with quality by design, late-stage PD and process characterization preferred.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately paymore or less than the posted range. This range may be modified in the future. ​
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​
• This job is eligible to participate in our short-term incentive programs. ​

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and untilpaid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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